BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    FILM DIGITZER, MODEL 2908 MAMMO PRO

    K Number: K063424 · Decision Dec 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    3
    Review Days
    38

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    Basic Information

    Device Name
    FILM DIGITZER, MODEL 2908 MAMMO PRO
    K Number
    K063424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Array Corp.
    Date Received
    November 13, 2006
    Decision Date
    December 21, 2006
    Product Code
    LMA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LMA Digitizer, Image, Radiological

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    Other Clearances by Array Corp.

    K Number Device Name
    K033637 MEDICAL IMAGE DIGITIZER, MODEL 2908
    K982785 FILM DIGITIZER MODEL 2905